KR900015749A - Interleukin-1 formulation - Google Patents

Interleukin-1 formulation Download PDF

Info

Publication number
KR900015749A
KR900015749A KR1019900004797A KR900004797A KR900015749A KR 900015749 A KR900015749 A KR 900015749A KR 1019900004797 A KR1019900004797 A KR 1019900004797A KR 900004797 A KR900004797 A KR 900004797A KR 900015749 A KR900015749 A KR 900015749A
Authority
KR
South Korea
Prior art keywords
composition
biologically active
tromethamine
mannitol
protein
Prior art date
Application number
KR1019900004797A
Other languages
Korean (ko)
Inventor
펭 차이 켈리
코나드 바이소르 게리
마리 네프 빅토리아
칠리앙 구 레오
치앙 히-쉬
Original Assignee
신텍스(유. 에스. 에이) 인코포레이티드
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 신텍스(유. 에스. 에이) 인코포레이티드 filed Critical 신텍스(유. 에스. 에이) 인코포레이티드
Publication of KR900015749A publication Critical patent/KR900015749A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2006—IL-1
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Abstract

내용 없음.No content.

Description

인터루킨-1제형Interleukin-1 formulation

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is an open matter, no full text was included.

제1도 a 및 b도는 시간 경과에 따른 생성물의 안정성을 나타내는 SDS-폴리아크릴아미드 겔 전기영동의 결과를 도시한다.1 a and b show the results of SDS-polyacrylamide gel electrophoresis showing the stability of the product over time.

Claims (21)

생물학적 활성 재조합 인터루킨-1단백질(1L-1)의 무정형, 동결건조된 혼합물 및 약제학적으로 허용되는 부형제를 포함함을 특징으로 하는, 비경구 투여가능한 수성 제형의 형성에 적합한 약제학적 조성물.A pharmaceutical composition suitable for forming a parenterally administrable aqueous formulation, characterized in that it comprises an amorphous, lyophilized mixture of biologically active recombinant interleukin-1 protein (1L-1) and a pharmaceutically acceptable excipient. 제1항에 있어서, 부형제가 매트릭스를 형성하는 조성물.The composition of claim 1 wherein the excipients form a matrix. 제2항에 있어서, 부형제 매트릭스가 연장된 시간에 걸쳐 혼합물을 무정형으로 유지시키기에 충분한 양으로 존재하고 약제학적으로 허용되는 주사용액으로 환원될때 생리적으로 허용되는 pH를 설정하는 조성물.The composition of claim 2 wherein the excipient matrix is present in an amount sufficient to keep the mixture amorphous over an extended period of time and establishes a physiologically acceptable pH when reduced to a pharmaceutically acceptable injectable solution. 제1항, 2항 및 3항중 어느 한 항에 있어서, 부형제 매트릭스가 (a) 폴리하이드록실화된, 비-단백질, 1L-1, 혼합성 화합물 및 (b) 트로메타민의 배합물인 조성물.The composition of claim 1, wherein the excipient matrix is a combination of (a) polyhydroxylated, non-protein, 1L-1, mixed compound, and (b) tromethamine. 제1항 내지 4항중 어느 한 항에 있어서, 생물학적 활성 인터루킨-1이 1L-1β인 조성물.The composition of claim 1, wherein the biologically active interleukin-1 is 1L-1β. 제1항 내지 4항중 어느 한 항에 있어서, 생물학적 활성 인터루킨-1이 1L-1α인 조성물.The composition of claim 1, wherein the biologically active interleukin-1 is 1L-1α. 제1항 내지 6항중 어느 한 항에 있어서, 1L-1혼화성 화합물이 약 1 내지 5중량%(%W)의 동일 농도의 만니톨 및 당인 조성물.The composition of any one of claims 1 to 6, wherein the 1L-1 miscible compound is mannitol and sugar at about the same concentration of about 1 to 5% by weight (% W). 제7항에 있어서, 1L-1 혼화성 화합물이 3중량%의 동일농도의 만니톨 및 당인 조성물.8. The composition of claim 7, wherein the 1L-1 miscible compound is 3% by weight of equal concentrations of mannitol and sugars. 제1항 내지 8항중 어느 한 항에 있어서, 0.010% 1L-1β를 함유하는 조성물.The composition of any one of claims 1 to 8 containing 0.010% 1L-1β. 제1항 내지 8항중 어느 한 항에 있어서, 0.002% 1L-1β를 함유하는 조성물.The composition of any one of claims 1 to 8 containing 0.002% 1L-1β. 제10항에 있어서, 추가적으로 HSA를 함유하는 조성물.The composition of claim 10 further comprising HSA. 제1항 내지 11항중 어느 한 항에 있어서, 수용액 형태인 조성물.The composition of claim 1 in the form of an aqueous solution. 제12항에 있어서, 조성물이 1L-1, 폴리하이드록실화된, 비-단백질, 1L-1혼화성 화합물 및 생리적으로 허용될 수 있는 pH로 완충된 약제학적으로 허용될 수 있는 주사용 액체를 함유하는 조성물.13. The composition of claim 12, wherein the composition comprises 1 L-1, polyhydroxylated, non-protein, 1 L-1 miscible compound and a pharmaceutically acceptable injectable liquid buffered at physiologically acceptable pH. Containing composition. 제12항 또는 13항에 있어서, 0.01중량% 내지 0.5중량% 범위의 농도로 트로메타민을 사용해 완충시킨 수성 조성물.The aqueous composition according to claim 12 or 13, which is buffered with tromethamine at a concentration ranging from 0.01% to 0.5% by weight. 제12, 13 및 14항중 어느 한 항에 있어서, 1L-1이 1 내지 100㎍/㎖범위 내의 농도인 1L-1β인 조성물.The composition according to any one of claims 12, 13 and 14, wherein 1L-1 is 1L-1β having a concentration in the range of 1 to 100 µg / ml. 제12항에 있어서, a) 1 내지 100㎍/㎖의 본질적으로 순수한 1L-1, b) 1 내지 5중량% 용량(w/v) 만니톨, c) 1 내지 5% w/v자당 및 d) 0.01 내지 5% 트로메타민으로 필수적으로 이루어진, 사람의 체내 주사에 적합한 생물학적 활성 1L-1의 조성물.13. The composition of claim 12, wherein a) 1 to 100 μg / ml of essentially pure 1L-1, b) 1 to 5 wt% dose (w / v) mannitol, c) 1 to 5% w / v sucrose and d) A composition of biologically active 1L-1 suitable for in vivo injection of humans consisting essentially of 0.01 to 5% tromethamine. 제16항에 있어서, 생물학적 활성 1L-1이 1L-1β인 조성물.The composition of claim 16, wherein the biologically active 1L-1 is 1L-1β. 제17항에 있어서, a) 0.01%의 본질적으로 순수한 1L-1β, b) 3중량% 용량(w/v) 만니톨, c) 3% w/v 자당 및 d) 0.12% 트로메타민을 함유하는 사람의 체내 주사에 적합한 생물학적 활성 1L-1β의 조성물.18. The composition of claim 17 comprising a) 0.01% essentially pure 1L-1β, b) 3% by weight dose (w / v) mannitol, c) 3% w / v sucrose and d) 0.12% tromethamine A composition of biologically active 1L-1β suitable for in vivo injection in humans. 제16항 또는 17항에 있어서, 1L-1 또는 1L-1β농도가 0.002%이고, 부가적으로 1% HSA를 함유하는 조성물.18. The composition of claim 16 or 17, wherein the 1L-1 or 1L-1β concentration is 0.002% and additionally contains 1% HSA. 본질적으로 순수한 재조합 1L-1단백질의 수용액 및 약제학적으로 허용되는 부형제를 동결 건조시킴을 특징으로 하여, 제1항 내지 19항중 어느 한 항에 따른 조성물을 제조하는 방법.20. A process for the preparation of a composition according to any one of claims 1 to 19, characterized in that the solution is essentially freeze dried an aqueous solution of the recombinant 1L-1 protein and a pharmaceutically acceptable excipient. 제1항 내지 19항중 어느 한 항에 있어서, 화학요법, 방사능치료법 또는 질환의 결과로서 억압된 후 면역시스템이 반응하도록 유도하는데 사용하기 위한 조성물.The composition of claim 1 for use in inducing the immune system to respond after being suppressed as a result of chemotherapy, radiotherapy or disease. ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.※ Note: The disclosure is based on the initial application.
KR1019900004797A 1989-04-07 1990-04-07 Interleukin-1 formulation KR900015749A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US33517589A 1989-04-07 1989-04-07
US335175 1989-04-07

Publications (1)

Publication Number Publication Date
KR900015749A true KR900015749A (en) 1990-11-10

Family

ID=23310616

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1019900004797A KR900015749A (en) 1989-04-07 1990-04-07 Interleukin-1 formulation

Country Status (7)

Country Link
EP (1) EP0391444A3 (en)
JP (1) JPH0314520A (en)
KR (1) KR900015749A (en)
AU (1) AU631623B2 (en)
CA (1) CA2014103A1 (en)
NZ (1) NZ233242A (en)
ZA (1) ZA902663B (en)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990006127A1 (en) * 1988-12-06 1990-06-14 Otsuka Pharmaceutical Co., Ltd. STABILIZED COMPOSITION OF INTERLEUKIN-1$g(b)
JP2818834B2 (en) * 1991-08-12 1998-10-30 大塚製薬株式会社 IL-1α stabilized pharmaceutical preparation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6991790B1 (en) 1997-06-13 2006-01-31 Genentech, Inc. Antibody formulation
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
DE60139944D1 (en) 2000-10-12 2009-10-29 Genentech Inc LOW VISCOSIS CONCENTRATED PROTEIN FORMULATIONS
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
PT1610820E (en) 2003-04-04 2010-12-16 Novartis Ag High concentration antibody and protein formulations
JP4392187B2 (en) * 2003-04-15 2009-12-24 株式会社 サトウスポーツプラザ Muscle building equipment
FR2881139A1 (en) * 2005-01-26 2006-07-28 Agronomique Inst Nat Rech Liquid for lyophilization of proteins, useful for stabilizing pharmaceuticals or analytical proteins, comprises a filler, stabilizer, buffer and optionally nonionic surfactant
MX2009005984A (en) * 2006-12-06 2009-06-16 Wyeth Corp High protein concentration formulations containing mannitol.
WO2009127248A1 (en) * 2008-04-16 2009-10-22 United Technologies Ut Ag Cosmetic and dermatological compositions and kits containing interleukin-1 alpha
CN102209552A (en) 2008-11-07 2011-10-05 联合技术Ut股份公司 Compositions containing interleukin-1 and peptides
SG174258A1 (en) 2009-03-06 2011-10-28 Genentech Inc Antibody formulation
EA023680B1 (en) * 2009-03-17 2016-06-30 Общество С Ограниченной Ответственностью "Сенгара" Interleukin-1 beta in cosmetic compositions and methods for use thereof
MX2011009572A (en) * 2009-03-17 2011-09-28 United Technologies Ut Ag Topical compositions comprising interleukin-1 alpha and peptides and cosmetic methods thereof.

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1955245A1 (en) * 1968-11-04 1970-06-11 Abbott Lab Xylitol preparation for intravenous injec - tion
US4604377A (en) * 1984-03-28 1986-08-05 Cetus Corporation Pharmaceutical compositions of microbially produced interleukin-2
WO1985004328A1 (en) * 1984-03-28 1985-10-10 Cetus Corporation Pharmaceutical compositions of microbially produced interleukin-2
JPH07100663B2 (en) * 1985-12-23 1995-11-01 大日本製薬株式会社 Infectious disease prophylactic / therapeutic agent containing interleukin 1 as an active ingredient
JPH0645551B2 (en) * 1986-01-07 1994-06-15 塩野義製薬株式会社 Interleukin-2 composition
GB8604983D0 (en) * 1986-02-28 1986-04-09 Biocompatibles Ltd Protein preservation
EP0284249A1 (en) * 1987-03-13 1988-09-28 Interferon Sciences, Inc. Lyophilized lymphokine composition
JPH0676332B2 (en) * 1988-03-09 1994-09-28 大塚製薬株式会社 Stabilized composition of interleukin-1β
JPH0649656B2 (en) * 1988-08-04 1994-06-29 大塚製薬株式会社 Thrombocytopenia treatment
JPH02111726A (en) * 1988-10-19 1990-04-24 Dainippon Pharmaceut Co Ltd Stabilization of human interleukin 1
JPH02157231A (en) * 1988-12-07 1990-06-18 Bio Kagaku Kenkyusho:Kk Cytostatic agent

Also Published As

Publication number Publication date
AU631623B2 (en) 1992-12-03
JPH0314520A (en) 1991-01-23
EP0391444A2 (en) 1990-10-10
ZA902663B (en) 1991-12-24
CA2014103A1 (en) 1990-10-07
NZ233242A (en) 1992-11-25
EP0391444A3 (en) 1992-03-04
AU5301090A (en) 1990-10-11

Similar Documents

Publication Publication Date Title
KR100221123B1 (en) Stabilized gonadotropin containing preparations
KR900015749A (en) Interleukin-1 formulation
EP0619119B1 (en) Stabilized parathyroid hormone composition
KR100491281B1 (en) Stabilized Albumin-Free Recombinant Factor Ⅷ Preparation having a Low Sugar Content
US5919443A (en) Stable lyophilized pharmaceutical preparations of G-CSF
RU2001122722A (en) New compositions of exendin agonists and methods for their administration
RU94033520A (en) Injected lecithin gel
KR890003400A (en) Bioactive Peptide Powder Composition (Formulation) for Nasal Administration
RU96105951A (en) PHARMACEUTICAL COMPOSITIONS WITH THE NERVE GROWTH FACTOR
SI9420048B (en) Pharmaceutical formulations of nerve growth factor
KR960000923A (en) Preparation of Monomeric Insulin Analogs
JPH0853361A (en) Stable protein-containing freeze-drying preparation and assay kit
KR100397034B1 (en) Non-inorganic salt solution for nasal administration
KR900701174A (en) Phospholipid-containing compositions, methods for their preparation and use as excipients for pharmaceutical substances
SK137895A3 (en) Stable liquid compositions of gamma interferon
AR017973A1 (en) PHARMACEUTICAL ISOTONIC FORMULATION, USE OF SUCH FORMULATION IN THE PREPARATION OF A MEDICINAL PRODUCT FOR USE IN THE THERAPY OF AN AUTOIMMUNE DISEASE, AND METHOD FOR IMPROVING THE STORAGE OF AN ANTIBODY
JPH05331071A (en) Lyophilized composition of calcitonin gene-related peptide and stabilization thereof
US5635176A (en) Pharmaceutical compositions containing IL-6
US5384132A (en) Stabilized gonadotropin containing preparations
RU2214285C2 (en) Composition for using in disposable syringe
US5310727A (en) Pharmaceutical compositions for parenteral use containing a calcitonin as the active ingredient
US5270057A (en) Stabilized gonadotropin containing preparations
KR910005886A (en) Stabilized Leukocyte Interferon
JPS6360940A (en) Preventive or remedy for cataract
EA001579B1 (en) Lyophilized composition of bone morphogenic factor human mp52 and process for preparation the same

Legal Events

Date Code Title Description
A201 Request for examination
E902 Notification of reason for refusal
E601 Decision to refuse application